XII. Facility Registration and Regulatory Requirements

9am – 10.30am GMT+03:00, 14 November 2026 ‐ 1 hour 30 mins

Scientific session

Moderators: Jay Epstein, Karin van den Berg

Time Session Speaker
09:00 – 09:45 Facility registration and product market authorization
  • International regulatory frameworks and harmonization efforts
  • Overview of regulatory requirements for PDMPs
Jens Reinhardt
09:45 – 10:30 Preparing a Plasma Master File: comprehensive product registration dossiers, including documentation and clinical research considerations
Nigar Ertuğrul Örüç